Pediatric Diabetics Type 1 Using InsuPatch

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01368978
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : September 5, 2014
Information provided by (Responsible Party):
Insuline Medical Ltd.

December 21, 2010
June 8, 2011
September 5, 2014
December 2009
May 2012   (Final data collection date for primary outcome measure)
Efficacy [ Time Frame: one year ]
Insulin will be taken during the clamp and will be measured for concentration.The concentration of insulin during the first hour will be compared between the two arms for efficacy.
Same as current
Complete list of historical versions of study NCT01368978 on Archive Site
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Pediatric Diabetics Type 1 Using InsuPatch
Evaluation of the Effect of lnsuPatch on the Pharmacokinetic and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs Given as a Bolus by Continuous Subcutaneous Insulin Infusion (CSII)

This study is a prospective, single-center, open label, randomized; two-arms cross over study.

This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.

Twenty(20) type 1 children with Type 1 Diabetics Mellitus (TIDM) who are meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.

The study will consist of an outpatient enrollment visit and two admissions(One clamps with the InsuPatch and one clamp without the InsuPatch) . Each Subject will thus serve as his/her own control.

Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Device: InsuPatch
device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.
  • Experimental: Test (with the InsuPatch device)
    Device use
    Intervention: Device: InsuPatch
  • No Intervention: Control (without the InsuPatch device)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 12-17 (inclusive)
  2. Clinical diagnosis of T1DM at least one year's duration
  3. On CSII therapy for at least three months
  4. Hemoglobin A1c(HBA1C) values below 10% and above 6.5%
  5. Minimum weight requirements of at least 37.9 Kg.
  6. Ability to comprehend written and spoken English
  7. Body Mass Index z-score below 90%

Exclusion Criteria:

  1. Celiac disease, gastroparesis, or other gastrointestinal disorder associated with alerted carbohydrate absorption or intestinal motility.
  2. Medication besides insulin known to alter blood glucose, gastric motility, or intestinal carbohydrate absorption
  3. Female subjects of reproductive potential who are pregnant or breast feeding
  4. Inability to comprehend written and spoken English
  5. Any other condition, which in the judgment of the investigators, would interfere with the subject's or parents' ability to provide informed consent or the investigator's ability to perform the study.
  6. Hematocrit below 35 or serum potassium below 3.4 (confirmed by two samples)
Sexes Eligible for Study: All
12 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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Insuline Medical Ltd.
Insuline Medical Ltd.
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Principal Investigator: Eda Cengiz, MD Yale University
Insuline Medical Ltd.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP